Nipple-Sparing Mastectomy Shown to Be Safe—and Increasingly Preferred

In more than 500 risk-reducing nipple-sparing mastectomies in 348 deleterious BRCA-mutation carriers, we identified no cases of primary breast cancer on the side of the prophylactic procedure.

— James Jakub, MD

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Prophylactic mastectomy that preserves a woman’s nipple is oncologically safe in patients with deleterious BRCA mutations, according to the largest study yet to evaluate this approach in this high-risk population. “In more than 500 risk-reducing nipple-sparing mastectomies in 348 deleterious BRCA-mutation carriers, we identified no cases of primary breast cancer on the side of the prophylactic procedure,” said James Jakub, MD, a breast surgeon at the Mayo Clinic, Rochester, Minnesota.

Because of its superior cosmetic outcomes, nipple-sparing mastectomy has gained in popularity among women having prophylactic mastectomies, but its use in high-risk BRCA patients has remained somewhat controversial.

In a press briefing, Dr. Jakub noted: “Leaving the nipple behind gives patients pause,” but he explained that most breast cancers develop deeper in the breast, in the terminal ductal lobular units. Contemporary nipple-sparing mastectomies should leave behind few, if any, terminal ductal lobular units. There still remains a slight risk for cancer to develop in the nipple, areola, and breast, although these are rare occurrences.

Study Details and Results

At the 2016 American Society of Breast Surgeons (ASBrS) Annual Meeting, Dr. Jakub described the outcomes of 348 women harboring the BRCA1 (n = 204) or BRCA2 (n = 144) mutation. Patients underwent 551 prophylactic nipple-sparing mastectomies at 9 institutions from 1968 to 2013. Although all the mastectomies in the series were prophylactic, 145 patients had a single breast removed prophylactically after a diagnosis of a current or previous cancer in the contralateral breast and therapeutic surgery. The remaining 203 patients had bilateral prophylactic mastectomies. Patients found to have an occult cancer in a prophylactically removed breast were excluded from the study.

After a median follow-up of 34 months, none of the patients who had bilateral nipple-sparing mastectomy developed breast cancer, Dr. Jakub reported. There were seven breast cancer deaths, but all were in women who had concurrent or previous cancer in the contralateral breast at the time of prophylactic surgery, and their stage IV disease was attributed to preexisting cancer. There were five other deaths not related to breast cancer.

Breast surgical oncologists find ourselves asking not whether we can spare the nipple-areolar complex, but when do we really need to remove it?

— Tina J. Hieken, MD

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Dr. Jakub acknowledged the follow-up is “relatively short,” but he said other studies join this one in providing “cumulative evidence” of the appropriateness of this risk-reducing procedure. Moreover, he added, the use of nipple-sparing mastectomy at the Mayo Clinic has significantly increased in recent years. In 2009, about 8% of mastectomies performed spared the nipple; this number jumped to 30% within 5 years.

Recommendations for Surgeons

Surgical oncologist Tina J. Hieken, MD, also of the Mayo Clinic, shared her recommendations to surgeons at the 2016 ASBrS Annual Meeting. She noted that the improved aesthetics associated with retention of the native nipple-areolar complex “have fueled tremendous demand” for nipple-sparing mastectomy. Not only is cosmesis better, she said, but one-stage reconstruction is facilitated.

“This has led to a shift in philosophy,” Dr. Hieken said. “Breast surgical oncologists find ourselves asking not whether we can spare the nipple-areolar complex, but when do we really need to remove it?” In other words, not only has nipple-sparing mastectomy proved to be oncologically safe in BRCA-mutation carriers, but even in patients with active cancer, surgeons can retain the nipple under certain circumstances, she explained.

Update on Nipple-Sparing Mastectomy

The use of nipple-sparing mastectomy is rapidly growing, in both prophylactic and therapeutic situations.

In a study from the Mayo Clinic, no cases of breast cancer recurrence were observed among 551 nipple-sparing procedures in women with deleterious BRCA mutations who did not have cancer at the time of surgery.

Outside of a few contraindications, nipple-sparing mastectomy may be acceptable for women with active cancer as well.

The initial criteria for patient selection in this group used to be quite stringent, according to Dr. Hieken, but with encouraging data and longer follow-up, factors have emerged that can help select patients. “The data would suggest we can broaden our selection criteria,” she added.

For prophylactic mastectomy, sparing the nipple—or at least discussing the possibility—is endorsed by the ASBrS, the National Comprehensive Cancer Network® (NCCN®), and the European Society of Medical Oncology. For therapeutic mastectomy, the NCCN still recommends removal of the nipple for most patients but acknowledges nipple-sparing mastectomy can be considered for women with favorable tumors located ≥ 2 cm from the nipple. This is a cautious approach, she added, considering the “shift in clinical practice.”

Dr. Hieken synthesized the current data on nipple-sparing mastectomy into these clinical recommendations for patients with breast cancer:

Nipple-sparing mastectomy is acceptable in node-negative patients with small tumors of favorable biology that do not lie immediately underneath the nipple;

Nipple-sparing mastectomy can be used with caution in patients with multicentric tumors, clinically node-positive tumors, and tumors presenting with skin retraction;

Nipple-sparing mastectomy is contraindicated in patients with inflammatory breast cancer, tumors involving the nipple, and tumors that present with pathologic nipple discharge.

Patient-related factors should also be considered, she added. The most favorable candidates for nipple-sparing mastectomy are patients who are young, healthy nonsmokers with small- to medium-sized breasts and no or minimal ptosis. Dr. Hieken does not recommend this approach for patients who are active smokers or for women who are not candidates for immediate breast reconstruction. It is “cautionary” in patients who are obese, have had extensive radiation or breast surgery, have extremely large breasts with significant ptosis, and have medical comorbidities that can increase the complication risk.

Finally, she offered a checklist of questions to help guide the decision regarding nipple-sparing mastectomy: What is the likelihood the nipple margin is positive? Can all glandular tissue be removed through this aesthetic incision? What is the estimated long-term risk of local tumor recurrence? Will the cosmetic outcome “truly” be exceptional? And will the patient be satisfied with the results? ■